Module232025

07/05/2025

Dir 2001/83/EC Dir 2009/35/EC Reg (EC) 726/2004 Reg (EC) 141/2000 Reg (EC) 1901/2006

New Directive

New Regulation

The Organisation for Professionals in Regulatory Affairs

27 x national implementation

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Proposed revised EU legislation

New Directive is very similar to new Regulation

These slides are based on the new Regulation

“The merger of the Orphan Regulation and the Paediatric Regulation with the legislation applicable to all medicinal products will allow for simplification and increased coherence.” ? Let’s look at the evidence…

The Organisation for Professionals in Regulatory Affairs

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